Prospective, randomised evaluation of efficacy of antidepressant monotherapy and antidepressant combinations in the treatment of patients with resistant depression

ISRCTN ISRCTN65259480
DOI https://doi.org/10.1186/ISRCTN65259480
Secondary identifying numbers IGA MZ CR NS 10368-3
Submission date
03/09/2010
Registration date
27/09/2010
Last edited
27/09/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Martin Bares
Scientific

Prague Psychiatric Center
Ústavni 91
Prague 8-Bohnice
181 03
Czech Republic

Study information

Study designSingle centre two arm open label randomised active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleRandomised, open-label study comparing the efficacy of antidepressant monotherapy and antidepressant combinations in the acute treatment of patients with resistant depression
Study acronymD-REZ-KOMB
Study objectivesThe aim of our study is to examine efficacy of antidepressant monotherapy and combinations of antidepressants in the treatment of resistant depression in common clinical practice. We will test the following null hypotheses:
1. That the reduction of depressive symptoms does not differ between monotherapy and combinations groups
2. The number of responders in both groups does not differ
Ethics approval(s)The Ethics Committee of Prague Psychiatric Centre approved on the 21st May 2008
Health condition(s) or problem(s) studiedResistant depressive disorder
InterventionPatients will be randomly allocated to antidepressant monotherapy group or combination of antidepressant group. Specific antidepressant will be chosen by attending psychiatrist according to clinical judgment and with regard to the history of previous treatment. Antidepressant or combinations of antidepressant will be used in the dose cited in Summary of Products. Both interventions are defined as a new intervention not augmentation of previous antidepressant treatments. We will administer combinations that are commonly used in clinical practice. The total duration of treatment is 6 weeks. We will evaluate stability of outcome in responders after 2 months.
Intervention typeOther
Primary outcome measureThe change in the Montgomery-Asberg Depression Rating Scale (MADRS). Patients will be rated at baseline, week 2 week 4 and the end of acute treatment and responders after 2 month of treatment.
Secondary outcome measuresResponse to treatment that is defined as a greater than or equal to 50% reduction of MADRS score from baseline to the end of treatment.
Overall study start date01/01/2009
Completion date30/06/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants60 participants
Key inclusion criteria1. Patients suffering from major depressive disorder (recurrent or single episode) diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) criteria, confirmed using the Mini-International Neuropsychiatric Interview (MINI) Czech version 5.0.0.
2. Patients fulfilling at least Stage I criteria for resistant depression according to Thase and Rush, 1997
3. The mental ability to understand and sign Informed Consent Form
4. The score in Montgomery-Asberg Depression Rating Scale greater than or equal to 25 and the score in Clinical Global Impression greater than or equal to 4
5. Outpatients and inpatients
6. Age between 18 and 65 years
Key exclusion criteria1. Contraindications of used antidepressant treatments according to Summary of product (SPC)
2. The use of antidepressants as a monotherapy or as a part of combination that were ineffective in the treatment of current episode
3. The use of antipsychotics, thymostabilizers and other biological treatment of depression (ECT, rTMS, sleep deprivation etc.) during the study (anxiolytics and hypnotics for case of severe anxiety and insomnia are permitted) as well as formal psychotherapy
4. Comorbidity of Axis I and II (DSM IV) disorders in the 6 month before enrollment to the study
5. Severe or uncontrolled somatic disorders, likely to cause depressive symptoms or interfere with the conduct of the study
Date of first enrolment01/01/2009
Date of final enrolment30/06/2011

Locations

Countries of recruitment

  • Czech Republic

Study participating centre

Prague Psychiatric Center
Prague 8-Bohnice
181 03
Czech Republic

Sponsor information

Ministry of Health (Czech Republic) - Internal Grant Agency
Government

Palackeho nam.4
Prague 2
128 01
Czech Republic

Website http://www.mzcr.cz
ROR logo "ROR" https://ror.org/00y6khe77

Funders

Funder type

Government

Ministry of Health (Czech Republic) - Internal Grant Agency (ref: No. NS 10368-3)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan